ES2966151T3 - Intermittent infusion device - Google Patents

Abstract

Systems and methods for microinfusion of medical fluids are described. Microinfusion systems may include a pump, a patient interface, a tube between the pump and the interface, and a microinfusion device along the tube. A first portion of the tube above the microinfusion device is longer than a second portion of the tube below the device. The microinfusion device may include a chamber in line with the tube, a first valve between the chamber and the first portion of the tube, a second valve between the chamber and the second portion of the tube, and a third valve between the chamber. and a discharge chamber. The second valve may be slidably arranged within the chamber. A medical fluid may be provided in the chamber that slides the second valve by displacing another fluid in the chamber through the third valve into the discharge chamber. (Automatic translation with Google Translate, without legal value)

Description

DESCRIPTION

Intermittent infusion device

Technical field of the invention

The present disclosure generally relates to the administration of medical fluids by infusion and, in particular, relates to systems and methods for delivering and pumping medical fluids.

Background of the invention

Infusion pumps have become commonplace within the healthcare industry as devices for precisely administering intravenous (TV) fluids. Using a pump instead of an elevated fluid container with a simple roller clamp to control the flow of IV fluid allows for more precise and consistent control of the rate of fluid delivery to the patient.

The set of tubing, valves, fittings, and needles that connect the fluid container to the patient can be called an IV set. IV sets are typically disposable to reduce the risk of infection and contamination. In some infusion pump/IV set systems, a drug is provided to be administered to the patient in or on top of the pump. In these systems, a fluid such as saline is provided to the patient and fills the tubing between the pump and the patient before the drug reaches the patient. In some systems, a milliliter or more of fluid may be wasted in the tubing which, pumping at one milliliter per hour, can cause a delay of up to an hour before the drug reaches the patient. These systems can be undesirable in some situations if care is not taken.

US 5049 129 A, US 2005/182383 Al and US 4 834 705 A are directed to the passive administration of the beneficial agent to the intravenous system of a patient, to a coupling for the transmission of medical liquids and to a drug dispensing system.

Brief Description of the Invention

The invention is defined by the subject matter of claim 1, while other embodiments are defined in the dependent claims. Below, portions of the description and drawings referring to embodiments that are not covered by the claims are not presented as embodiments of the invention, but as examples useful for understanding the invention.

The technology aspects of the topic relate to the microinfusion of medical fluids using a microinfusion device. The microinfusion device may include one or more chambers, one or more fixed valves, and one or more sliding valves, and may be disposed of in an intravenous (IV) set between an infusion pump and a patient. As described in more detail below, the valves and chambers of the microinfusion device can be arranged and configured to facilitate the infusion of a medical fluid to a patient without the need to provide large volumes of saline or other solutions to the patient.

According to one aspect, a microinfusion device is provided that includes a first chamber having an inlet port and an outlet port. The microinfusion. The device also includes a first valve disposed between the inlet port and the first chamber. The microinfusion device also includes a second valve disposed on a movable piston that is movable within the first chamber. The microinfusion device also includes a second chamber disposed adjacent to the first chamber. The microinfusion device also includes a third valve disposed between the first chamber and the second chamber. The microinfusion device also includes a needleless port configured to fluidly engage the first chamber.

In accordance with one aspect, an intravenous (IV) set is provided that includes the first tube configured to couple to a fluid source. The IV system also includes a microinfusion device with an inlet port attached to the first tube. The microinfusion device also includes a first chamber having an inlet port and an outlet port, a first valve disposed between the inlet port and the first chamber, a second valve disposed on a movable piston movable within the first chamber, a second chamber disposed adjacent to the first chamber, a third valve disposed between the first chamber and the second chamber, a needleless port having a port chamber fluidly coupled to the first chamber and an outlet port. The IV set also includes a second tube attached to the outlet port.

According to a certain aspect, which is not part of the invention, there is provided a method that includes delivering a first fluid through a first chamber and an outlet port of a microinfusion device with an infusion pump. The method also includes providing a second fluid into the first chamber from a port fluidly coupled to the first chamber. The method also includes displacing, upon providing the second fluid, a portion of the first fluid in the first chamber into a second chamber. The method also includes supplying the second fluid from the first chamber through the outlet port with the infusion pump.

It is understood that various configurations of the subject technology will be readily apparent to those skilled in the art of the disclosure, wherein various configurations of the subject technology are shown and described by way of illustration. As you will notice, the subject's technology is capable of other and different configurations and its various details are capable of modifying in various other aspects, all without departing from the scope of the subject's technology. Accordingly, the brief description, the drawings and the detailed description should be considered illustrative in nature and not restrictive.

Brief description of the drawings

The accompanying drawings, which are included to provide further understanding and are incorporated into and constitute a part of this specification, illustrate the disclosed embodiments and together with the description serve to explain the principles of the disclosed embodiments. In the drawings:

Figure 1 is a diagram of a system for administering medical fluid to a patient using an IV pump and a microinfusion device in accordance with certain aspects of the present disclosure.

Figure 2 illustrates a cross-sectional view of a microinfusion device in accordance with certain aspects of the present disclosure.

Figure 3 illustrates the cross-sectional view of a syringe according to certain aspects of the present disclosure.

Figures 4A-4D illustrate cross-sectional views of a microinfusion device in various configurations in accordance with certain aspects of the present disclosure.

Figure 5 illustrates an enlarged cross-sectional side view of a portion of the microinfusion device of Figure 4B in accordance with certain aspects of the present disclosure.

Figure 6 illustrates a cross-sectional view of a microinfusion device with an outlet port in a discharge chamber in accordance with certain aspects of the present disclosure.

Figure 7 illustrates a cross-sectional view of a microinfusion device in accordance with certain aspects of the present disclosure.

Figure 8 illustrates a cross-sectional view of a microinfusion device in accordance with certain aspects of the present disclosure.

Figure 9 illustrates the top view of a portion of a pump cassette according to a certain aspect of the present disclosure.

Figure 10 illustrates a flow chart of an example process for microinfusion according to various aspects of the technology in question.

Detailed description of the invention

The detailed description below describes various configurations of thematic technology and is not intended to represent the only configurations in which thematic technology can be practiced. The detailed description includes specific details in order to provide a full understanding of the subject technology. Accordingly, dimensions can be provided. regarding certain aspects as non-limiting examples. It will be apparent to those skilled in the art that the subject technology can be implemented without these specific details. In some cases, well-known structures and components are shown in block diagram form in order to avoid obscuring the concept of the subject technology.

It should be understood that the present disclosure includes examples of the technology at issue and does not limit the scope of the appended claims. Various aspects of the technology in question will now be disclosed in accordance with particular, but not limiting, examples. Various embodiments described in the present disclosure can be carried out in different ways and variations, and according to a desired application or implementation.

In the following detailed description, numerous specific details are set forth to provide a complete understanding of the present disclosure. It will be apparent, however, to one skilled in the art that the embodiments of the present disclosure can be practiced without some of the specific details. In other cases, well-known structures and techniques have not been shown in detail so as not to obscure the disclosure.

According to various embodiments, a microinfusion device is provided. The microinfusion device may be delivered at a location along an infusion line between an infusion pump and a patient. The microinfusion device can facilitate the administration of a volume of drug doses to the patient (e.g., an infant, such as a prematurely born baby), without large volumes to prepare or flush the infusion line.

The microinfusion device can be used to deliver the drug dose into the infusion line at a location close to the patient. To reduce delivery start time, while allowing the pump to control the delivery rate and allowing a smooth return to, for example, saline delivery (or delivery of any other administered drug compatible with microinfusion solution, such as D5W) after dosing is complete. The microinfusion device may also provide the additional benefit of allowing observation of the progress of dose delivery in some embodiments. The microinfusion device may be configured to facilitate administration of target volumes between, for example, 0.5 cc and 5 cc at flow rates between 0.05 cc/hr or 0.1 cc/hr and 10 cc/hr (as examples). . More details about the microinfusion device are provided below.

While the following discussion is directed toward the administration of medical fluid to a patient by a caregiver using an IV pump, the methods and configurations disclosed can be used for other medical and non-medical applications and may be used by others (e.g. , a patient self-administering a medical liquid at home).

Figure 1 is a diagram of a system 100 for administering medical fluids to a patient. As shown, an infusion system 100, such as a neonatal infusion system, may include an infusion pump 102 that controls the administration of a medical fluid to a patient 110 via tubing fluidly coupled between the pump 102 and the patient 110. In In the example of Figure 1, patient 110 is a newborn, such as a prematurely born baby or a premature baby.

The infusion system 100 may include a multi-chamber device, such as the microinfusion device 106, which is integrated with tubing extending between the pump 102 and the patient 110. The microinfusion device 106 may be used to administer intermittent infusions of small doses of a medicine to a patient, such as an infant. In the example of Figure 1, tube 104 fluidly couples microinfusion device 106 to pump 102 and tube 108 fluidly couples microinfusion device 106 to patient 110. Tube 104 may be substantially longer than tube 108, so that a medical fluid, such as a liquid drug for the patient 110, can be introduced into the tube at a location close to the patient. In this way, a dose of drug can be introduced into the infusion line through the microinfusion device 106 at a location close to the patient to reduce the start time of administration.

A fluid such as saline or other medical liquids can be delivered from the pump 102 to the tube 104 in a controlled manner. As shown, the pump 102 may include a display 109, control features 112, and pump mechanism 114. Liquids to be pumped into the tube 104 may be supplied from a fluid source located in the pump mechanism (e.g. For example, a syringe or vial loaded into the pump mechanism) or through a fluid container (for example, an IV bag) are discarded above the pump and fluidly coupled through the inlet 116 of the pump (for example, through a length of tubing and/or a pump cassette connected to the tubing that is connected to the fluid container). The tubing of the IV set may interact with the pump 102 through a length of tubing that the pump 102 captures and manipulates or the IV set may include a pump cassette integrated with the tubing (above the microinfusion device) that is configured to be received in a cassette well of the pump and that includes various valves, pistons and/or other controllable component configured to be operated by the pump 102 to move fluids through the assembly IV. In configurations where the IV set includes a pump cassette, the pump cassette may include an encoded identifier (e.g., a barcode) or an RFID tag that identifies the set (e.g., including the identification aspect , such as chamber volumes and/or microinfusion device valve cracking pressures).

Figure 2 shows an enlarged cross-sectional side view of the microinfusion device 106. As shown in Figure 2, the microinfusion device 106 may be a multi-chamber device having a first chamber 200 and a second chamber 202. The tube 104 can be coupled to the first chamber 200 by an inlet valve 206 disposed between an inlet port 250 of the chamber 200 and the chamber 200 itself. The inlet valve 206 may be a check valve that allows the fluid 226 (e.g. , saline) flow from tube 104 into chamber 200, if the cracking pressure of valve 206 is reached, and which prevents fluid flow from chamber 200 into tube 104.

A second valve, such as the sliding outlet valve 208, may also be provided in the chamber 200. As shown, the sliding outlet valve 208 may be connected to a movable piston 210 that is configured to move within the chamber 200 that responds to various fluid pressures in the valve 208. The sliding outlet valve 208 may be, for example, a check valve that allows fluid 226 to flow through the valve from chamber 200 to tube 108 if it is reached. the cracking pressure of the valve 208 when the piston 210 and valve 208 are located at the bottom of the chamber 200 as in the configuration of Figure 2. The tube 108 can be coupled to the chamber 200 at an outlet port 252.

An inlet port 204, such as a needleless valve, may also be coupled to chamber 200 via fluid path 240. Needleless valve 204 may, for example, be a SmartSite® needleless valve, as provided by Becton, Dickinson and Company. As shown in Figure 2, the needleless valve 204 may include a compressible valve member 205 (e.g., a silicone valve member) disposed in a chamber 207. As discussed in more detail below, a medical fluid as a liquid drug can be introduced into chamber 200 through needleless port 204 for administration to the patient. Piston displacement of liquid in chamber 200 (e.g., by movement of piston 210 and valve 208) occurs when fluid is introduced through needleless valve 204, with direct flow through piston 210 prevented. through valve 208.

In various embodiments, tubes 104 and 108 and device 106 may be primed prior to attaching tube 108 to the patient. Priming the system may include using a syringe on top of device 106 to generate enough pressure to break valves 206 and 208 to allow fluid to flow into chamber 200 and tube 108 and/or using an override mechanism (not shown explicitly) into valve 208 to allow fluid to flow into chamber 200 and tube 108.

The device 106 may include an additional valve 220 disposed between the chamber 200 and the chamber 202 that allows fluid 226 to flow from the chamber 200 into the chamber 202 when the cracking pressure of the valve 220 is reached (e.g., a valve retention). The valve 220 also prevents the flow of fluid from the chamber 202 to the chamber 200. In this way, the chamber 202 can be configured as an overflow chamber or a discharge chamber so that fluid such as fluid 226 can be poured from the chamber 200 to chamber 202. As shown, valve 220 may be disposed at one end (e.g., a top end or a pump side end of a wall separating chambers 200 and 202) distal to the end at which port 204 and fluid path 240 are formed (for example, a lower end or a patient side end). With this configuration of chambers 200 and 202 and valve 220, only the liquid located at the top (pump side) of chamber 200 can be pushed through valve 220 into chamber 202. With this configuration of chambers 200 and 202 and valve 220, the entire volume of chamber 200 can be passed to discharge chamber 202, as the microinfuser is loaded with a drug from port 204 or line 108. In the configuration shown in Figure 2, the valve mounted on the piston 208 is prevented because the piston 210 moves beyond (e.g., above) the valve 220. With this configuration of chambers 200 and 202 and valves 208 and 220, only Fluid above valve 208 and piston 210 (e.g., fluid 226) can pass through valve 220, and fluid introduced into chamber 200 from port 204 or line 108 can be prevented from passing through. through valve 220 into chamber 202 via valve mounted on piston 208.

A vent such as vent 222 (e.g., pump side) may be provided at the top of chamber 202 that allows air in chamber 202 to escape to the external environment if fluid 226 flows into chamber 202 from chamber 200, a filter 224 may be provided in the vent 222 to prevent contaminants from flowing into or out of the chamber 202 and to prevent discharge liquid from being expelled from the chamber while allowing air to escape. Exhaust air through breather 222 prevents pressure from building up in the discharge chamber. The filter 224 may be, for example, a sterilizing quality filter, such as a 0.2 micron filter, a check valve and/or a hydrophobic/hydrophilic membrane or the like that prevents fluid loss from the chamber 202 and allows air to exit chamber 202. A 0.2 micron filter may be used to prevent microbial contamination of the environment by the exhaust air. A medical fluid, such as a liquid drug to be administered to the patient, may be supplied into the source of chamber 200, such as a syringe that is connected to port 204. Figure 3 shows a cross-sectional view of an example of a syringe. no needle 300 filled (e.g., in a pharmacy or by a caregiver) with a medical fluid 302 (e.g., a liquid drug). A. Plunger 306 may be configured to compress to deliver fluid 302 through a needleless outlet port 304 of the syringe.

Referring again to Figure 2, in various embodiments, chambers 200 and 202 can be configured to contain, for example, 10 cc and 20 cc of fluid. Chambers 200 and 202 may have a common volume or may have different volumes. Chamber 202 may have a volume determined by the number of doses for which the microinfusion device is expected to be used. For example, the device 106 can be configured to be used for the infusion of two doses of a medication without being replaced. In this example, chamber 202 may have a volume of approximately 2.5 times the volume of the expected dose, so that a volume of fluid 226 equal to dose volume two of the liquid drug may be stored within chamber 202. The example of two doses is merely illustrative. In some embodiments, the number of doses can be chosen based on the frequency of the planned infusion and the length of a nursing shift, such that a single IV set with a single microinfusion device can be used for the entire nursing shift. Nursing.

The crack pressures of valves 206, 208, and 220 can be configured so that valve 206 has the lowest crack pressure, valve 220 has the highest crack pressure, and valve 208 has a crack pressure between crack pressure of valves 206 and 220 for proper control of fluids through device 106. By way of example, valve 206 may have a crack pressure less than 2 psi, valve 208 may have a crack pressure between 5 psi and 10 psi, and valve 220 may have a crack pressure equal to or greater than the maximum pressure of the pump (e.g., equal to or greater than about 20 psi). In this way, the pump can provide pressure to move fluid 226 through valves 206 and 208 without cracking valve 220. Valve 220 can be configured to crack in response to pressure generated by a syringe connected to port 204. Valve 208 may have a cracking pressure greater than the pressure required to slide piston 210 (to which valve 208 is connected) into chamber 200, thus valve 208 may be configured to move to the bottom. of chamber 200 (as in the configuration of Figure 2) by fluid 226 before valve 208 cracks. However, the above examples where the cracking pressure of valve 206 is less than the cracking pressure of valve 208 are merely illustrative. In these examples, the cracking pressure of valve 206 is low to avoid occlusion alarms. However, in some embodiments, valve 206 may have a crack pressure equal to or greater than the crack pressure of valve 208 and less than the crack pressure of valve 220.

The set IV that includes the device 106 may have a set ID that can be scanned or otherwise provided to the pump 102. Upon recognition of the set by the pump based on the set ID, the pump 102 may reconfigure the maximum pump pressure to allow a reasonable cracking pressure of the valve 220, to facilitate filling of the chamber 200 (for example, to reduce the syringe force necessary to displace the piston 210). Additionally, medication errors may be reduced due to the combination of a set ID and the microinfusion technology described herein. For example, with a set ID (e.g., a cassette barcode or RFID), the pump 102 can identify a microinfusion system associated with a specific dosed medication and tubing chamber volumes, and can control the pressures of line and/or volumes infused to ensure correct administration of the expected dose.

Figures 4A, 4B, 4C and 4D show cross-sectional views of the microinfusion device 1.06 in various stages of operation during the infusion of a medical fluid to a patient.

In the configuration of Figure 4A, fluid 226 flows from tube 104, through valve 206 (as indicated by arrow 400), through chamber 200 (as indicated by arrow 402) and through from valve 208 (as indicated by arrow 404) toward outlet tube 108 (e.g., toward the patient) under the control of pump 102 (see Figure 1).

In the configuration of Figure 4B, the syringe 300 has been connected to the needleless valve 204, the plunger 306 is being compressed (as indicated by the arrow 412), and the medical fluid 302 is being pushed into the chamber 200 (as indicated by the arrow 410). In this configuration, chamber 200 may have a proximal portion (e.g., pump side) 450 behind/above piston 210 and a distal portion (e.g., patient side) 452 in front of (below) piston 21.0 . The distal portion 452 (when the piston 210 is moved from the fully forward position) contains the microinfuser drug 302, while the proximal portion 450 behind the piston contains only the IV fluid 226, the pressure generated by the flow of fluid 302 in The chamber 200 has pushed the piston 210 and the valve 208 upward, that is, in the direction of the valve 206. Because the valve 206 prevents any backward flow in the tube 104, a portion 226D of the fluid 226 flows to through valve 220 into chamber 202 (as indicated by arrow 414). Fluid 226D may displace air from chamber 202 such that the air is vented to the outside environment through vent 222 (as indicated by arrow 416). As shown in Figure 4B, the compressible member 205 can be compressed by the syringe 300 to prevent the flow of fluid 302 directly from the syringe to the patient. In this way, fluid 302 can be supplied into chamber 200. However, in other embodiments, the compressible member 205 can be replaced by another component, such as a mechanism or other type of valve that prevents the flow of fluid 302 directly from the syringe to the patient and allows fluid flow into chamber 200. Piston 210 and valve 208 separate drug 302 from fluid 226. Piston 210 (sometimes called plunger) can be configured so that if the piston is pushed 210, can be configured. To the top (pump side) of chamber 200, plunger 210 blocks access to valve 220, thereby preventing drug 302 from flowing into chamber 202. In this way, dilution can be prevented. of drug 302 and/or imprecise dosing administration.

In the configuration of Figure 4C, syringe 300 has been removed from valve 204, leaving fluid 302 in chamber 200. In this configuration, pump 102 continues to pump fluid 226 into chamber 200 through valve 206. (as indicated by arrow 420) causing fluid 226 to push piston 210 and valve 208 downward toward tube 108. This downward pressure on piston 210 and valve 208 moves piston 210 and valve 208 downward, thereby pushing medical fluid 302 out of chamber 200 and into tube 108 (as indicated by arrow 422) (e.g., to be delivered to the patient) under the control of pump 102.

In the configuration of Figure 4D, all of the medical fluid 302 has been pushed from the chamber 200 (for example, and is supplied to the patient) and the fluid 226 perfectly follows the fluid 302 of the chamber 200 when the piston 210 and the valve 208 reach the bottom of chamber 200 to resume delivery of fluid 226 through device 106 (e.g., to the patient). In this configuration, fluid 226 flows back through valve 206 (as indicated by arrow 430), through chamber 200 (as indicated by arrow 432), and through valve 208 (as indicated by arrow 434) into the outlet tube 108 (e.g., to the patient) under control of the pump 102 while the poured portion 226D of the fluid 226 remains inside the chamber 202, as shown in Figure 4D, the amount of fluid 226D poured into chamber 202 may be less than half the volume of the chamber, so that an additional dose can be provided in the same manner described above in connection with Figures 4A-4C without replacing the IV set or the microinfusion device. 106. Because the amount of fluid 226D in chamber 202 is equal to the amount of drug introduced into chamber 200 and provided to the patient, the amount of drug delivered and/or the number of doses delivered can be measured. observing the amount of fluid 226D in chamber 202 and/or observing a witness line or “trust line” formed by the front of the plug/plunger 210.

As shown in Figure 4D, chamber 207 may be fluidly coupled to chamber 200, so that fluid 226 automatically flushes chamber 200, chamber 207, and tubes 108 when fluid 226 is pushed through the device. 106 after administration of fluid 302 to the patient.

Figure 5 is an enlarged cross-sectional view of a portion of the microinfusion device 106 in the configuration of Figure 4B with the syringe 300 connected to port 204. As shown in Figure 5, when the syringe 300 is connected to port 204, The outlet port 304 of the syringe 300 compresses the compressible member 205 such that a path 502 is opened for fluid 302 to flow from the syringe 300 into the chamber 200 and such that a front portion 500 of the compressible member 205 extends toward port 240 to close port 240, thereby preventing fluid 302 from being provided directly to the patient from syringe 300 and separating fluid 302 from being diluted by fluid 226.

In the embodiments described above, the fluid 226D that is poured from the chamber 200 into the chamber 202 when the medical fluid 302 is introduced into the chamber 202 is simply stored within the chamber 202 until the assembly IV, including the device 106, is removed and replaced. However, this is merely illustrative. As shown in Figure 6, in some embodiments, chamber 202 may be provided with an outlet port 600 such as another needleless valve (e.g., a SmartSite® valve or an open Luer port with a cap) through which A caregiver such as a nurse can withdraw fluid 226 from chamber 202 (for example, by connecting a syringe without a needle to port 600). In this embodiment, when fluid 226D is removed from chamber 202, air can flow into chamber 202 through breather 222. The low airflow resistance of filter 224 compared to the high cracking pressure of the valve 220 prevents fluid from being removed from chamber 200.

In other embodiments, chamber 202, separated from chamber 200 by valve 220, may be implemented as a remote chamber that is fluidly connected to chamber 200 via tubing. In these embodiments, a benefit may be provided that the second chamber (overflow) could be much larger than the first chamber 200 (for example, to contain the overflow of many doses). Additionally, providing a remote camera can help eliminate a large volume of the patient's immediate space. In another embodiment, chamber 202, separated from chamber 200 by valve 220, may be replaced by a syringe coupled to chamber 200.

As noted above, it may be desirable to be able to observe the progress of dosing during dosing. As shown in Figure 7, the chamber 200 may be provided with graduated markings 700 so that a caregiver can directly measure the amount of medication 302 that has been delivered into the chamber 200 and monitor how much of the drug has subsequently been administered to the patient in at any time (for example, by observing the trust line of the plunger at or in relation to the graduated marks).

As shown in Figure 8, in another embodiment, the chamber 202 may have graduated markings 800 so that the amount of drug 302 that has been introduced into the chamber 200 can be measured indirectly by observing the amount of fluid 226D in the chamber 202. In this way, the fluid 226D can store a record of the amount of drug 302 that has been provided in the chamber 202, since the amount of fluid 226D in the chamber 202 will not change as the fluid 302 is administered to the patient. or after administration of fluid 302. In other embodiments, both chambers 200 and 202 may be provided with graduated marks so that real-time observation can be provided (e.g., using marks 700) of the amount of drug 302 being administered. is administering and a historical record (e.g., using markings 800) of the amount of drug 302 infused.

The device 106 may be provided as an integral part of an IV set (e.g., an IV set including tubing 104 and 108, a fluid container connected to tubing 104, or a catheter assembly). The set IV may include a cartridge coupled to tube 104, the cartridge configured to be installed in pump 102 and manipulated to pump fluid into tube 104. As shown in Figure 9, a cartridge 900 may have an identifier 902 (e.g. , a barcode or other encoded identifier, or radio frequency identification (RFTD) that includes a set identifier (ID) and/or a set type) that identifies the components of the IV set, including the microinfusion device. In this way, the pump 102 can be provided with the features of the microinfusion device and can set operating limits and configure sensors to detect any operating problems in the IV system, including the microinfusion device. Examples of operating limits and the use thereof based on the characteristics of a medical device coupled to an infusion pump can be found, for example, in US Patent No. 8,038,593.

Figure 10 represents a flow chart of an example process for microinfusion, according to the aspects of the technology in question. For explanatory purposes, the example process of Figure 10 is described in this document with reference to the components of Figure 1-Figure 9. Additionally, for explanatory purposes, the blocks of the example process of Figure 10 are described in this document as occurring serially, or linearly. However, multiple blocks of the example process in Figure 10 can occur in parallel. Furthermore, the blocks of the example process of Figure 10 do not need to be performed in the order shown and/or one or more of the blocks of the example process of Figure 10 do not need to be performed.

In the example flow diagram depicted, at block 1000, a first fluid (e.g., a saline solution such as fluid 226, as described herein) may be supplied through a first chamber, such as chamber 200, and an outlet port, such as outlet port 252, of a microinfusion device, such as microinfusion device 106, with an infusion pump, such as infusion pump 102. For example, the first fluid may be delivered through the exit port to a patient (for example, through tubes such as tube 108 attached to the exit port and a catheter in the patient). The delivery of the first liquid through the first chamber of the microinfusion device with the infusion pump may include the delivery of the first fluid through a first valve, such as valve 206, into the first chamber and the delivery of the first fluid out. from the first chamber through a second valve, such as valve 208 which is arranged on a movable piston, such as movable piston 210.

In block 1002, a second fluid, such as a liquid drug (e.g., fluid 302, as described herein), may be supplied to the first chamber from a port, such as port 204, that is fluidly coupled to the first camera. The delivery of the second fluid into the first chamber from the port that is fluidly coupled to the first chamber may include compressing a compressible member of the port to open a fluid path between a syringe and the first chamber and close a fluid path between the first chamber and the output port.

In block 1004, at least a portion of the first fluid from the first chamber may be displaced to a second chamber (e.g., chamber 202) providing the second fluid. The air in the second chamber may be displaced through a vent such as vent 222 in the second chamber with the portion of the first fluid. Displacing, by providing the second fluid, a portion of the first fluid from the first chamber to the second chamber may include pushing, with the second fluid, the movable piston and the second valve toward the first valve. Moving, in providing the second fluid, a portion of the first fluid in the first chamber to the second chamber may also include pushing, with the movable piston and the second valve, the portion of the first fluid through a third valve, such as the valve 220, arranged between the first chamber and the second chamber.

In block 1006, the second fluid can be supplied from the first chamber through the outlet port with the infusion pump. After supply of the second fluid, an additional first fluid may be provided through the first chamber and the outlet port, while the portion of the first fluid remains in the second chamber. In some scenarios, the first fluid portion may be removed from the second chamber through a port such as port 600 in the second chamber.

The subject technology is illustrated, for example, in accordance with various aspects described above.

The subject technology is illustrated, for example, in accordance with various aspects described above. The present disclosure is provided to enable any person skilled in the art to practice the various aspects described herein. The disclosure provides several examples of the subject technology, and the subject technology is not limited to these examples. Various modifications to these aspects will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other aspects.

A reference to a singular element is not intended to mean “one and only one” unless specifically stated, but rather “one or more.” Unless specifically stated otherwise, the term “some” refers to one or more. Pronouns in the masculine (for example, her) include the feminine and neuter gender (for example, she and her) and vice versa. Titles and subtitles, if any, are used for convenience only and do not limit the invention.

The word “exemplary” is used in this document to mean “to serve as an example or illustration.” Any aspect or design described herein as “exemplary” should not necessarily be construed as preferred or advantageous over other aspects or designs. In one aspect, various alternative configurations and operations described herein can be considered as at least equivalent.

As used in this document, the phrase “at least one of” preceding a series of elements, with the triplet “or” to separate any of the elements, modifies the list as a whole, rather than each element of list, the phrase “at least one of” does not require the selection of at least one item; rather, the phrase allows for a meaning that includes at least one of any of the elements, and/or at least one of any combination of the elements, and/or at least one of each of the elements. By way of example, the phrase “at least one of A, B or C” may refer to: only A, only B or only C; or any combination of A, B and C.

A phrase such as an “aspect” does not imply that said aspect is essential to the subject technology or that said aspect applies to all configurations of the subject technology. A disclosure related to an aspect may apply to all configurations, or to one or more configurations. An aspect may provide one or more examples. A phrase such as an aspect can refer to one or more aspects and vice versa. A phrase such as a “realization” does not imply that said realization is essential to the subject's technology or that said realization applies to ah configurations of the subject's technology. A disclosure relating to one embodiment may apply to all embodiments, or one or more embodiments. An embodiment may provide one or more examples. A phrase such modality may refer to one or more embodiments and vice versa. A phrase such as a “configuration” does not imply that such configuration is essential to the subject technology or that such configuration applies to all configurations of the subject technology. A disclosure related to a configuration may apply to all configurations, or to one or more configurations. A configuration can provide one or more examples. A phrase such configuration may refer to one or more configurations and vice versa.

In one respect, unless otherwise indicated, all measurements, values, classifications, positions, magnitudes, sizes and other specifications set forth in this specification, including in the following statements, are approximate, not exact. In one aspect, they are intended to have a reasonable range that is consistent with the functions to which they relate and with what is customary in the art to which they belong.

It is understood that the specific order or hierarchy of steps, or operations in the disclosed processes or methods are illustrations of exemplary approaches. Depending on preferences or implementation scenarios, it is understood that the specific order or hierarchy of steps, operations or processes may be reorganized. Some of the steps, operations or processes can be performed simultaneously. In some preferences or deployment scenarios, certain operations may or may not be performed. Some or all steps, operations or processes may be performed automatically, without user intervention. The accompanying method states that it presents elements of the various steps, operations or processes in a sample order, and is not intended to be limited to the specific order or hierarchy presented.

All structural and functional equivalents to elements of the various aspects described throughout this disclosure that are known or later become known to those skilled in the art are intended to be encompassed by the claims. Furthermore, nothing disclosed herein is intended to be dedicated to the public, regardless of whether such disclosure is explicitly recited in the claims. Furthermore, to the extent that the term “include,” “have,” or the like is used, such term is intended to be inclusive in a manner similar to the term “understand” as “understand” is interpreted when used as a transitional word in a vindication.

The title, background, brief description, brief description of the drawings and summary of the disclosure are incorporated into the disclosure and are provided as illustrative examples of the disclosure, not as restrictive descriptions. They are presented with the understanding that they will not be used to limit the scope or meaning of the claims. Also, in the description

detailed of the invention, it can be seen that the description provides illustrative examples and the various features are grouped into various embodiments for the purpose of streamlining the disclosure. This method of disclosure should not be construed as reflecting the intention that the claimed invention requires more features than are expressly stated in each claim.

Rather, as the following statements reflect, the subject matter lies in less than all the characteristics of a single revealed configuration or operation.

The claims are not intended to be limited to the aspects described herein, but will be given the full scope consistent with the language of the claims and encompass all legal equivalents.

Claims (15)

1. A microinfusion device (106), comprising: a first chamber (200) with an input port (250) and an output port (252); a first valve (206) arranged in the first chamber (200) between the inlet port (250) and an interior volume of the first chamber (200); a second valve (208) arranged on a piston (210) that can be moved within the first chamber (200); a second chamber (202) arranged adjacent to the first chamber (200); and a third valve (220) arranged between the first chamber (200) and the second chamber (202), wherein the third valve (220) is a single fluid coupling between the first chamber (200) and the second chamber (202). 2. The microinfusion device (106) of claim 1, wherein the first valve, the second valve and the third valve are each check valves. 3. The microinfusion device (106) of claim 2, wherein the first valve (206) has a first crack pressure, wherein the second valve (108) has a second crack pressure, wherein the third valve ( 220) has a third cracking pressure, wherein the first cracking pressure is less than the second cracking pressure, and where the second cracking pressure is less than the third cracking pressure. 4. The microinfusion device (106) of claim 1, further comprising a vent (222) coupled between the second chamber (202) and an external environment. 5. The microinfusion device (106) of claim 4, wherein the vent (222) comprises a filter (224) or a check valve. 6. The microinfusion device (106) of claim 4, wherein the inlet port (250) is configured to receive a first fluid (226) from a first tube (104) coupled to the inlet port (250). 7. The microinfusion device (106) of claim 6, further comprising a needleless port (204) fluidly coupled to the first chamber (200). 8. The microinfusion device (106) of claim 7, wherein the movable piston (210) is configured to move towards the first valve (206) by a second fluid (302) introduced into the needleless port (204) by a syringe without a needle (300) and to push a part of the first fluid (226) through the third valve (220) into the second chamber (202). 9. The microinfusion device (106) of claim 4, further comprising an outlet port (600) fluidly coupled to the second chamber (202). 10. The microinfusion device (106) of claim 9, wherein the outlet port (600) is a needleless valve configured to receive a needleless syringe (300) for extraction of the first fluid (226D) from the second camera (202). 11. The microinfusion device (106) of claim 10, wherein the third cracking pressure of the third valve (220) is greater than the resistance to air flow in the second chamber (202) through the vent (222). ), preventing the additional first fluid (226) from being introduced into the second chamber (202) from the first chamber (200) during the extraction of the first fluid (226D) from the second chamber (202). 12. An intravenous (IV) set comprising: the microinfusion device (106) of any of claims 1 to 10; a first tube (104) coupled to the inlet port (250); and a second tube (108) coupled to the outlet port (252). 13. The set IV of claim 12, further comprising a pump cassette coupled to the first tube (104), the pump cassette configured to interface with an infusion pump (102) and having an assembly identifier. 14. The set IV of claim 12, further comprising a fluid container fluidly coupled to the first tube (104). 15. The set IV of claim 12, further comprising a catheter assembly coupled to the second tube (108).